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Trial · Interventional

Enrolling by invitationNot applicableRegistry data

Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)

NCTNCT06966687 (opens ClinicalTrials.gov in a new tab)Other idPANDA XI
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Thymosin alpha-1, does not test it. It appears in the description.

Overview

Status
Enrolling by invitation
Phase
Not applicable
Enrollment
200 participants (estimated)
Sponsor
Nanjing Medical University · Other
Design
Randomized · Double masking
Countries
1 country

China

Start
1 Apr 2025
Primary completion
31 Dec 2026 (estimated)
Completion
31 Dec 2026 (estimated)
First posted
13 May 2025
Last update posted
14 Jan 2026
Conditions
Aortic Dissection · Aortic Dissection Aneurysm

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. N/A

    Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)

    NCT06966687

    1 Apr 2025 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with acute aortic syndrome (AAS). Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 in addition to antiinflammatory treatment may be beneficial. This study was designed to test the hypothesis that the administration of Ulinastatin and Thymosin α1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.

Interventions

  • Ulinastatin and Thymosin α1Drug
  • Ulinastatin onlyDrug

Arms2

  • Experimental

    UT Group

    Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery

  • Active comparator

    Control Group

    Ulinastatin (100000U TID for 5 days) immediately after surgery

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The mean Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery

    Time frame · within the prior 7 days after surgery.

    Registry description

    The occurrence of new-onset organ failure and new-onset persistent organ failure (Sequential Organ Failure Assessment (SOFA) score. New-onset is defined as events that occur after randomization and not present 24 hours before randomization.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2017

10 results

Effect of ulinastatin combined with thymosin alpha1 on sepsis: A systematic review and meta-analysis of Chinese and Indian patients.

Liu et al. 2017Journal of critical carecited by 27

PMID 28069319DOI 10.1016/j.jcrc.2016.12.013PUB-28069319

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset; * Patients with acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled. * The patients' age between 18 \~90 years old. * Agree to participate in the study and sign the informed consent. Exclusion Criteria: * Patients allergic to Thymosin α1 or Ulinastatin; * Lactating women and pregnant women; * Patients with mental diseases, drug and alcohol dependence; * Refuse to participate in this study and refuse to sign the informed consent.

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